2018-04-30 - Unknown
901876426
| Adverse reaction report number | 901876426 |
| Latest AER version number | 0 |
| Market authorization holder AER number | CA201815253 |
| Initial received date | 2018-04-30 |
| Latest received date | 2018-04-30 |
| Age | N/A |
| Gender | Unknown |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Physician |
| Source of report | MAH |
| Report outcome | Unknown |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | |
| Hospitalization | |
| Other medically important | Yes |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 2.5 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | |
| AMFETAMINE | Concomitant | Attention deficit/hyperactivity disorder | |||||
| METHYLPHENIDATE | Concomitant | Attention deficit/hyperactivity disorder | |||||
| VORTIOXETINE | Concomitant | Unknown | Product used for unknown indication |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Dyskinesia | |